Trial Outcomes & Findings for Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint (NCT NCT01045694)
NCT ID: NCT01045694
Last Updated: 2017-10-06
Results Overview
TERMINATED
PHASE4
8 participants
twenty-four hours, ten days, twelve weeks, six months, and one year
2017-10-06
Participant Flow
Study had 8 enrollments: 6 completed and 2 withdrew voluntarily. Study was terminated early due to lack of funds. No data analysis was completed.
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group.
Participant milestones
| Measure |
Arthritis Treatment
Participants received one of three treatments:
* Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
* Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
* Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arthritis Treatment
Participants received one of three treatments:
* Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
* Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
* Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arthritis Treatment
n=8 Participants
Participants received one of three treatments:
* Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
* Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
* Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: twenty-four hours, ten days, twelve weeks, six months, and one yearPopulation: 8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: twelve weeks, six months, and one yearPopulation: 8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: twelve weeks, six months, and one yearPopulation: 8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Arthritis Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place