Trial Outcomes & Findings for A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia (NCT NCT01364259)

Results Overview

Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

17 participants

Primary outcome timeframe

1 year

Results posted on

2017-04-04

Participant Flow

Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. During their visit, a physician or research coordinator will explain the study. Patients will be given the informed consent form to read. If they agree to participate, they will be asked to sign the consent form prior to participating.

Patient's pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed.

Participant milestones

Participant milestones
Measure	Placebo Placebo and SRS CyberKnife stereotactic radiosurgery (srs)	Amifostine Amifostine and SRS CyberKnife stereotactic radiosurgery and Amifostine
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants Placebo and SRS CyberKnife stereotactic radiosurgery + saline	Amifostine n=8 Participants Amifostine and CyberKnife stereotactic radiosurgery CyberKnife stereotactic radiosurgery + amofostine	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: One subject randomized to drug arm did not have data.

Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo and SRS CyberKnife stereotactic radiosurgery (srs)	Amifostine n=7 Participants Amifostine and SRS CyberKnife stereotactic radiosurgery and Amifostine
Facial Numbness Following Radiosurgery	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.

Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo and SRS CyberKnife stereotactic radiosurgery (srs)	Amifostine n=7 Participants Amifostine and SRS CyberKnife stereotactic radiosurgery and Amifostine
Pain Relief Following Radiosurgery	9 Participants	5 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amifostine

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

Dr. Scott G. Soltys, Assistant Professor

Stanford University Cancer Center

Phone: 650.724.1569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place