Trial Outcomes & Findings for IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation (NCT NCT01931865)

Results Overview

visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

12 weeks

Results posted on

2015-12-31

Participant Flow

Participant milestones

Participant milestones
Measure	IncobotulinumtoxinA The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	IncobotulinumtoxinA The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IncobotulinumtoxinA n=12 Participants The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks

visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.

Outcome measures

Outcome measures
Measure	IncobotulinumtoxinA n=8 Participants The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Number of Participants With a Significant Reduction in Pain	8 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Advanced cancer patients

This quality of life scale consists of 10 questions regarding how pain affects your quality of life.

Outcome measures

Outcome measures
Measure	IncobotulinumtoxinA n=8 Participants The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Patients Who Show Improvement in American Pain Association Questionnaire	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Advanced cancer patients

The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).

Outcome measures

Outcome measures
Measure	IncobotulinumtoxinA n=8 Participants The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites. IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Patients Improved in Patient Global Impression of Change (PGIC) Scale	7 participants

Adverse Events

IncobotulinumtoxinA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bahman Jabbari M.D.

Yale University School of Medicine

Phone: 203-737-2464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place