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Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating

Primary Purpose

Hyperhidrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Botulinum Type B

Placebo

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Botulinum Toxin, Amputation, Phantom limb pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female, 18-50 years of age, active duty or retired military
Limb amputation (single or multiple:for lower extremity amputees, amputation at the ankle or above; for upper extremity amputees, amputation at the wrist or above)
Clear history of excessive sweating in a residual limb that is interfering with prosthesis fitting and functioning. This will be defined as focal, visible sweating in the region of the residual limb with at least one of the following characteristics: impairs prosthesis fitting, impairs functioning with a limb prosthesis
Negative urine pregnancy test prior to the administration of study medication (for females)

Exclusion Criteria:

Age less than 18 or greater than 50
Any medical condition that may put the participant at increased risk with exposure to Myobloc, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that may interfere with neuromuscular function
Females who are pregnant, breast feeding, or planning a pregnancy during the study, or who think they may be pregnant at the start of the study
Known allergy or sensitivity to any of the components in the study medication
Known sensitivity to human albumin or albumin transfusions
Current or planned use of aminoglycosides
Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled
Current or planned use of a myoelectric prostheses (for upper extremity amputees), as the potential for weakness caused by botulinum toxin could interfere with muscle contraction
Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment
Any condition or situation, in the investigator's opinion, that may put the participant at significant risk, confound the study results, or interfere significantly with the participant's ability to participate in the study
Any previous use of Myobloc, Dysport, or BOTOX

Sites / Locations

Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum Type B (Myobloc)

Saline solution

Arm Description

Each vial of active drug will contain 5000 unit/ml of Myobloc, with a total volume of 1 mL. The injections will be spaces 6 cm apart and will cover the entire area to be injected. Each site will receive a volume of 0.08 ml (400 units).

The volume to be injected will be calculated assuming the injectate is an active drug, and will therefore be an equivalent volume as an active drug (i.e. 0.08 mL per injection site with a 6 cm spacing interval)

Outcomes

Primary Outcome Measures

Amount of sweating

The amount of sweating will be assessed via gravimetry, which is an accepted method for determining sweating in a particular area. This method involves covering the area of the residual limb in question with filter paper for five minutes. After five minutes, the filter paper is removed and weighed. The weight of the dry filter paper is subtracted to give the approximate weight of the sweat produced. This study will use the total weight of sweat produced as a method of objectively quantifying the amount of sweating in the residual limb. Gravimetry will be used as a measure of change from pre-treatment to post-treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT01671800

First Posted

August 21, 2012

Last Updated

January 8, 2013

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01671800

Brief Title

Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating

Official Title

Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis Associated Symptomatic Sweating, or Residual Limb Hyperhidrosis in Amputees

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Walter Reed National Military Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a total enrollment of 32 amputee subjects.

Detailed Description

Patients with amputations experience severe sweating due to sockets and liners used with fitted prostheses. This excessive sweating causes inadequate fitting and function of the prosthesis as well as discomfort. The treatment modality and techniques used are based upon a successful prior open-labeled pilot study done by this research group investigating the effect of Botulinum Toxin A (BOTOX) on residual limb hyperhidrosis, which demonstrated significant decreases in sweating in amputees with residual limb hyperhidrosis treated with BOTOX. Each subject will undergo baseline testing consisting of 15 minutes of walking on a treadmill (or using a handcycle) at light exertion (11 on the Berg scale). They will report the effect of sweating on their prosthesis fit and function over the past month, and the amount of sweat produced in the 15 minutes will be measured via gravimetric assessment. At the end of the baseline session, subjects receive either the drug or placebo by injection into the residual limb area they identify as being the most troublesome for sweating. Subjects return for a 1-month follow-up session where the questionnaire, walking test, and sweat collection are re-administered. At the one-month follow-up session, subjects who received the placebo and felt it was not successful in decreasing their sweating are given the opportunity to cross-over into the drug arm of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperhidrosis

Keywords

Hyperhidrosis, Botulinum Toxin, Amputation, Phantom limb pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum Type B (Myobloc)

Arm Type

Experimental

Arm Description

Arm Title

Saline solution

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Botulinum Type B

Other Intervention Name(s)

Myobloc

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Amount of sweating

Description

Time Frame

one month after initial injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18-50 years of age, active duty or retired military Limb amputation (single or multiple:for lower extremity amputees, amputation at the ankle or above; for upper extremity amputees, amputation at the wrist or above) Clear history of excessive sweating in a residual limb that is interfering with prosthesis fitting and functioning. This will be defined as focal, visible sweating in the region of the residual limb with at least one of the following characteristics: impairs prosthesis fitting, impairs functioning with a limb prosthesis Negative urine pregnancy test prior to the administration of study medication (for females) Exclusion Criteria: Age less than 18 or greater than 50 Any medical condition that may put the participant at increased risk with exposure to Myobloc, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that may interfere with neuromuscular function Females who are pregnant, breast feeding, or planning a pregnancy during the study, or who think they may be pregnant at the start of the study Known allergy or sensitivity to any of the components in the study medication Known sensitivity to human albumin or albumin transfusions Current or planned use of aminoglycosides Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled Current or planned use of a myoelectric prostheses (for upper extremity amputees), as the potential for weakness caused by botulinum toxin could interfere with muscle contraction Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment Any condition or situation, in the investigator's opinion, that may put the participant at significant risk, confound the study results, or interfere significantly with the participant's ability to participate in the study Any previous use of Myobloc, Dysport, or BOTOX

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul F. Pasquina, M.D.

Organizational Affiliation

Walter Reed National Military Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21765248

Citation

Kern U, Kohl M, Seifert U, Schlereth T. Botulinum toxin type B in the treatment of residual limb hyperhidrosis for lower limb amputees: a pilot study. Am J Phys Med Rehabil. 2011 Apr;90(4):321-9. doi: 10.1097/PHM.0b013e31820636fd.

Results Reference

background

PubMed Identifier

15158547

Citation

Baumann LS, Halem ML. Botulinum toxin-B and the management of hyperhidrosis. Clin Dermatol. 2004 Jan-Feb;22(1):60-5. doi: 10.1016/j.clindermatol.2003.11.001.

Results Reference

background

PubMed Identifier

11939828

Citation

Hund M, Kinkelin I, Naumann M, Hamm H. Definition of axillary hyperhidrosis by gravimetric assessment. Arch Dermatol. 2002 Apr;138(4):539-41. doi: 10.1001/archderm.138.4.539. No abstract available.

Results Reference

background

PubMed Identifier

12752521

Citation

Flynn TC, Clark RE 2nd. Botulinum toxin type B (MYOBLOC) versus botulinum toxin type A (BOTOX) frontalis study: rate of onset and radius of diffusion. Dermatol Surg. 2003 May;29(5):519-22; discussion 522. doi: 10.1046/j.1524-4725.2003.29124.x.

Results Reference

background

PubMed Identifier

15841624

Citation

Baumann L, Slezinger A, Halem M, Vujevich J, Mallin K, Charles C, Martin LK, Black L, Bryde J. Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. Dermatol Surg. 2005 Mar;31(3):263-70. doi: 10.1111/j.1524-4725.2005.31071.

Results Reference

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Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating

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